Mild Hypertension, Prehypertension
Conditions
Keywords
Prehypertension, Mild hypertension, Flow mediated dilation, Hawthorn
Brief summary
Prehypertension and mild hypertension affect an estimated 157 million U.S. adults. Cardiovascular disease (CVD) risk and associated mortality is elevated in this population. Treatment options are limited consisting of lifestyle modification, which is often ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious, and acceptable treatment options for this population are needed. Hawthorn standardized extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have based dosage recommendations on animal studies. Therefore, the investigators propose a dose-finding study to measure the pharmacodynamic effect of three doses of standardized hawthorn extract and placebo.
Interventions
DIETARY_SUPPLEMENTHawthorn
Hawthorn standardized extract liquid capsule
DIETARY_SUPPLEMENTPlacebo capsule
Matched placebo liquid capsule
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Recent ambulatory daytime systolic BP average between 120 - 155 mmHg or diastolic BP between 80-95 mmHg 2. Age 18 years and older. 3. Ability to speak English
Exclusion criteria
1. Any antihypertensive medication use (ACE inhibitors, ARB, beta-blockers, calcium channel blockers, diuretics, alpha agonists or antagonists, nitrates, direct vasodilators such as hydralazine, aldosterone antagonists, direct renin inhibitors, endothelin antagonists) 2. Current tobacco use. 3. Diagnosed with diabetes, known coronary artery disease, severe aortic stenosis, idiopathic hypertrophic subaortic stenosis (IHSS), or upper extremity vascular obstruction. 4. Pregnancy or breast feeding. 5. Using estrogen-containing birth control methods. 6. Unwillingness to forgo vitamins C and E, fish oil, niacin, arginine, OTC decongestants, and NSAIDs such as advil, motrin, and nuprin during the study period. 7. Unwillingness to forgo use of phosphodiesterase inhibitors (sildenafil - 36 hours, vardenafil - 36 hours, tadalafil - 96 hours) prior to study visits. 8. Unwillingness to refrain from vigorous exercise on the morning of study visits. 9. Women with childbearing potential who do not agree to practice effective birth control (condom, diaphragm, cervical cap, copper IUD, abstinence).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FMD Max | 7d | Brachial artery flow mediated dilation max (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BP | 7d | Blood pressure |
Countries
United States
Outcome results
None listed